baxter high alert webinar part 2 proce suggested revisions

High-Alert Medications Heparin, Concentrated Electrolytes and Magnesium: Practical Strategies in Pursuit of Safety

© ISMP 2022 1

©2022 ISMP | www.ismp.org | 1

Christina Michalek, BS, RPh, FASHPMedication Safety Specialist

Susan Paparella, MSN, RN Vice President

Michelle Mandrack, MSN, RN Director of Consulting Services


This activity is funded by Baxter.


Pharmacy CE Activity Information & Accreditation

— This CE activity is jointly provided by ProCE, LLC and the Institute for Safe Medication Practices (ISMP). ProCE is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

— This CE activity is approved for 1.25 contact hours (0.125 CEU) in states that recognize ACPE providers.

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Online Evaluation and Statement of CompletionPharmacy CE

— www.ProCE.com

— Login with username and password

— Deadline: February 25, 2022

Attendance Code = ??????Attendance Code = ??????


Nursing CE information

—This activity has been approved for up to 1.25 California State Nursing contact hours by the provider, Debora Simmons, who is approved by the California Board of Registered Nursing, Provider Number CEP 13677.

ASHRM CE information—This activity has been approved for a total of 1.0 contact hours of

Continuing Education Credit toward fulfillment of the requirements of ASHRM designations of FASHRM (Fellow) and DFASHRM (Distinguished Fellow) and towards CPHRM renewal.

Visit ismp.org/node/28440 for details

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It is the policy of ISMP and ProCE, LLC to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation.

The speakers listed below have no relevant commercial and/or financial relationships to disclose:

Christina Michalek, BS, RPh, FASHP

Susan Paparella, MSN, RN Michelle Mandrack, MSN, RN

Please note: The opinions expressed in this activity should not be construed as those of the CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

Disclosure


Learning Objectives

Define• Define high-alert medications and their impact on patient safety

Describe

• Describe low scoring assessment items for heparin, concentrated electrolytes and magnesium from the ISMP Medication Safety Self Assessment® for High-Alert Medications

Cite • Cite at least two effective strategies each for harm prevention for heparin,

concentrated electrolytes and magnesium

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Speakers

Christina Michalek Susan Paparella Michelle Mandrack


Christina Michalek, BS, RPh, FASHPMedication Safety SpecialistInstitute for Safe Medication [email protected]

High-Alert Medications

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High-Alert Medications

Medications bearing a heightened risk of causing significant patient harm

when used in error.

While mistakes may or may not be more common, the

consequences of an error are more devastating to patients.

https://www.ismp.org/recommendations/high-alert-medications-acute-listhttps://www.ismp.org/recommendations/high-alert-medications-long-term-care-list

https://www.ismp.org/recommendations/high-alert-medications-community-ambulatory-list

©2022 ISMP | www.ismp.org | 10Davis NM, Cohen MR. Nursing. 1989 Jan;19(1):49-51.

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New ISMP Targeted Medication Safety Best Practice2022-2023

For each medication on the facility’s high-alert medication list, outline a robust set of processes for managing risk, impacting as many steps of the medication use process as feasible


Ensure that the strategies address system vulnerabilities in each stage of the medication use process (i.e., prescribing, dispensing, administering, and monitoring) and apply to prescribers, pharmacists, nurses, and other practitioners involved with medication use.

Avoid reliance on low-leverage risk-reduction strategies (e.g., applying high-alert medication labels on pharmacy storage bins, providing education) to prevent errors, and instead bundle these with mid- and high-leverage strategies.

Limit the use of independent double checks to select high-alert medications with the greatest risk for error in the organization. (e.g., chemotherapy, opioid infusions, IV insulin, heparin infusions).

Regularly assess for risk in the systems and practices used to support the safe use of medications by using information from internal and external sources (e.g., Joint Commission, ISMP).

Establish outcome and process measures to monitor safety and routinely collect data to determine the effectiveness of risk-reduction strategies.

New Best Practice

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ISMP Medication Safety Self Assessment® for High-Alert Medications

Tools and Process


Goals

— Assist providers assess the safety of systems and practices associated with 11 categories of high-alert medications

• Heighten awareness

• Identify and prioritize

• Create a national baseline

• Determine challengeshttps://www.ismp.org/assessments/high-alert-medications

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Assessment Items

380 critical safe medication systems and practice items

Selected by ISMP and an Advisory Group based on the types of errors and safety risks identified in these settings

Evidence-based items and consensus based expert opinions

Extends beyond minimum standards of practice


Power (Leverage)

HighMax: 16

MediumMax: 10

LowMax: 6

Items Weighted Based on Impact

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Scoring Guidelines

None• A. No activity to

implement• B. Discussed but not

implemented

Partial• C. Partially implemented

for some or all patients, orders, drugs, staff

• D. Fully implemented for some patients, orders, drugs, staff

Full • E. Fully implemented for

all patients, orders, drugs, staff


Heparin: Practical Strategies in Pursuit of Safety

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Unfractionated Heparin

— Potential for injury can be high

— Sub- or supra-therapeutic serum concentrations can lead to embolism or bleeding

— Standardizing care is a key strategy to avoid errors

— Maintaining therapeutic levels is important


ISMP Medication Safety Self Assessment®

High-Alert Medications: Anticoagulants

— Forty-three (43) self-assessment items

— General items, unfractionated heparin, low molecular weight heparin, direct oral anticoagulants and warfarin

— 564 facilities submitted the anticoagulant section

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Item # Self Assessment Item Mean None Partial Full

16 When orders for antithrombotic agents are entered, the computer order entry system alerts practitioners if the patient has received an antithrombotic (including anticoagulants), even a one-time dose, within the prior 24 hours in any location in the organization (e.g., emergency department, cardiac catheterization laboratory, interventional radiology), to ensure that adequate time has elapsed between doses of the same or different antithrombotic agent

47% 40% 31% 28%

Low Scoring Items


Item # Self Assessment Item Mean None Partial Full 7 Protocols and order sets identify the specific drugs,

interventions, and treatments (e.g., neuraxial procedures, certain vascular access procedures) that should be avoided in patients receiving anticoagulants

58% 26% 40% 34%

8 Protocols or guidelines exist to facilitate the transition between different anticoagulants

58% 30% 32% 38%

Low Scoring Items

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— Eighty-six-year-old woman prescribed enoxaparin

— Warfarin was added to the regimen

— A few days later, warfarin was stopped for a procedure and a heparin infusion was initiated; enoxaparin continued

Case Example


Item # Self Assessment Item Mean None Partial Full 3 The most recent laboratory value is automatically

displayed on order entry system screens when placing/verifying an order for an anticoagulant that is dose adjusted based on laboratory results

60% 32% 21% 47%

13 A standard, reliable process is in place for screening patients for recent anticoagulant use before invasive procedures; if therapy must be discontinued, protocols/guidelines define when anticoagulants should be stopped and restarted, and when alternative agents to bridge should be considered

64% 20% 42% 38%

36 Prior to ordering unfractionated heparin or using heparin-coated catheters/instruments, a history of heparin-induced thrombocytopenia (HIT) and/or allergy to heparin is determined and documented to generate an electronic alert

66% 13% 30% 57%

Low Scoring Items

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Item # Self Assessment Item Mean None Partial Full37a If HIT is suspected or diagnosed during current

therapy, there is a mechanism in place to ensure the following: All sources of unfractionated heparin and low molecular weight heparin (including use for arterial lines or catheter flushes) are discontinued

78% 14% 20% 66%

37b If HIT is suspected or diagnosed during current therapy, there is a mechanism in place to ensure the following: A prominent entry is placed in the patient’s medical record to alert staff to avoid the administration of, or exposure to, heparin in any form (including use for arterial lines or catheter flushes, heparin-coated catheters or instruments)

76% 15% 22% 63%

Low Scoring Items


Case Example

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Heparin infusion errors:

— Bolus or adjusted rate is not in alignment with the protocol

— Doses are calculated using an incorrect or inaccurate weight

— Wrong protocol followed

— Restarted at wrong time

— Provider ordered the wrong protocol

— Misinterpretation of the protocol

Other Unfractionated Heparin Risks


Item # Self Assessment Item Mean30 The variety of different unfractionated heparin (UFH) vial concentrations and sizes

is limited to only those needed in the facility97%

33 UFH Infusions are standardized to no more than two concentrations for neonates based on weight (e.g., less than 1 kg and 1 kg and greater)

95%

31 Only commercially prepared, premixed IV solutions of UFH are used (unless unavailable)

95%

32 UFH infusions are a standard concentration for adults and pediatrics 95%29 Weight based standard order sets / protocols are used for UFH 93%27 After start or change of UFH infusion, aPTT level taken no sooner than 6 hours

and every 24 hours once stable92%

34 Adults – commercially prepared unit-dose syringes of flush, or lock, or single-use vials are stocked in correct clinical areas

92%

High Scoring Items

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Other References

— Designed to highlight systems and practices related to safe use of antithrombotic agents

— Assist with proactive identification of opportunities to reduce hare with antithrombotic therapy

— Unfractionated heparin, low molecular weight heparin, direct thrombin inhibitors, factor Xa inhibitors, glycoprotein IIb-IIIa inhibitors, thrombolytics

https://www.ismp.org/assessments/antithrombotic-therapy


Susan Paparella MSN, RN Vice PresidentInstitute for Safe Medication [email protected]

High-Alert Medications:Concentrated Electrolytes

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High-Alert Medications: Concentrated Electrolyte Injection

— Twenty-six (26) self-assessment items• 9 items General Electrolyte Replacement Therapy

• 4 items for practices related to Potassium chloride

• 7 items for Hypertonic Sodium chloride (greater than 0.9%)

• 3 items for Phosphates (Potassium and Sodium)

• 2 items on Electrolytes used with Parenteral Nutrition

• 1 item regarding Organ Preservation Solutions

— 544 facilities submitted the concentrated electrolyte section

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# Self-Assessment ItemNone (A+B)

Partial (C+D)

Full (E)

9 System to proactively convert from IV to PO 55% 23% 22%

3 Standard order sets exist to prescribe electrolyte replacement including monitoring 22% 52% 27%

2b

Standard protocols exist for electrolyte replacement therapy that include the type and frequency of patient monitoring required\during IV administration and following therapy to evaluate the patient’s response

13% 50% 37%

2aStandard protocols exist for electrolyte replacement therapy that include MAXIMUM concentration and rate IV solutions including concentrations requirement for central line access 9% 34% 57%

High-Alert Self Assessment: General Electrolyte Replacement Therapy Lowest Scoring Items

ISMP Medication Safety Self Assessment® for High-Alert Medications- 2018 https://www.ismp.org/assessments/high-alert-medications

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Concentrated Potassium Chloride


Concentrated Potassium Chloride

ISMP MSA! 1996

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Fatal Event with Concentrated Potassium Chloride

ISMP MSA! 2021

www.ismp.org



Partial (C+D)

Full (E)

12 For maintenance infusions only manufactured, premixed potassium chloride solutions are used 13% 43% 44%

13For single/intermittent infusions for IV hypokalemia only, manufactured, premixed potassium chloride solutions, marked “highly concentrated” are used

11% 27% 61%

15In surgical locations, concentrated potassium chloride vials are sequestered in sealed kits and only obtained just before use

6% 18% 76%

High-Alert Self Assessment: Potassium Lowest Scoring


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Concentrated ElectrolytesInjectable Potassium Chloride Recommendations

— Limit access

— Limit compounding; Use prediluted standardized solutions

— Use automation/workflow systems for compounded electrolytes

— Segregate/sequester in storage; Avoid open access in ADCs matrix drawers or towers

— FMEA to identify risk

— Assess knowledge of risk



Concentrated Sodium Chloride

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Hypertonic Saline/Concentrated Sodium ChlorideClose Calls/Errors Reported to ISMP

— 500 mL infusion bags of Hypertonic Sodium Chloride (3%) stocked in Omnicell in place of 500 mL infusion bags of 0.9% Sodium Chloride

— A drug shortage of 3% solution; “on the fly” the pharmacy-prepared replacement using an automated IV compounder. Although the formula was entered, checked by a manager and an informatics pharmacist, a mathematical error resulted in a 6% product labeled as 3%. The sodium content on a 250mL container is listed as per liter, not per 250 mL, so the pharmacist mistakenly set up the proportion per liter adding too much sodium to the 500 mL bag. Several bags were dispensed, and several patients were exposed to the error before it was discovered

— Dosing errors mot uncommon during programming of smart infusion pumps because pediatric hypertonic sodium chloride prescribing information is dosed in mL/kg or mL/kg/hr but the smart infusion pump libraries list the solution in mEq/kg (bolus dose), mEq/kg/hr for the infusion

ISMP MSA! 2021


Concentrated Sodium Chloride

ISMP MSA! 2021

www.ismp.org

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Partial (C+D)

Full (E)

18Protocol/order set exists for each INDICATION for use of hypertonic saline 43% 27% 31%

19Protocol/order set exists for specific ADMINISTRATION and MONITORING for hypertonic saline 38% 25% 36%

22IV push doses of 23.4% sodium chloride are prepared in the pharmacy, labeled, and hand-delivered to urgent/critical care administrating provider

17% 28% 55%

203% sodium chloride infusions are restricted to pharmacy and/or approved areas in limited quantities 3% 22% 75%

High-Alert Self Assessment: Sodium ChlorideLowest Scoring Items



Concentrated ElectrolytesSodium Chloride Recommendations

— Set up standardized prescribing protocols for use; consider indication-based prescribing

— Limit access to pharmacy; limit quantities in critical areas• Special precautions for 23.4% Sodium chloride vials for neurologic emergencies

— Limit compounding; Use prediluted standardized solutions as much as possible

— Use automation/workflow systems when compounding sodium solutions• Set up standard formulations ahead of drug shortages or emergent need

— Segregate/sequester in storage; Avoid open access in ADCs matrix drawers or towers

— Require barcode scanning and smart infusion pump use; standardize library language with EHR

— FMEA to identify risk when stored in pharmacy and clinical locations


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Potassium Phosphate and Sodium Phosphate

Concentrated Phosphates


Concentrated Phosphates

IISMP MSA! 1996

www.ismp.org

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Concentrated Phosphate

— 2013 ISMP survey Parenteral Nutrition component shortages: Up to 28% participants reported errors including mix-ups of potassium phosphate & sodium phosphate

— Frequency- top 3 reported events

www.ismp.org

ISMP MSA! 2014


# Self-Assessment Item

None (A+B)

Partial (C+D)

Full (E)

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When IV Potassium Phosphate is prescribed, there is an automated or manual process in place to calculate the concomitant amount of potassium patients are to receive with each dose considering the patient’s potassium level and all other sources of electrolytes )maintenance fluids, PN or other replacement doses)

36% 28% 36%

25When possible, sodium phosphate is used to treat hypophosphatemia (rather than potassium phosphate) 35% 24% 41%

High-Alert Self Assessment: Potassium and Sodium Phosphate Lowest Scoring


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Concentrated ElectrolytesInjectable Phosphates Recommendations

— Establish replacement guidelines, (prescribing guidance based on levels of inorganic phosphate and clinical factors (age, renal function, indication); avoid ordering “an “amp”

— Practitioners use a standard, facility-defined dosing unit of measure (e.g., mmol vs. mEq) to prescribe, label, dispense, administer, and document doses of potassium phosphate for all adult, pediatric, and neonatal patients. All preparations should be made in the pharmacy

— Develop a process to calculate the concomitant amount of potassium patients are to receive with each dose considering the patient’s potassium level and all other sources of electrolytes) maintenance fluids, PN or other replacement doses); similar when using sodium phosphate

— Differentiate in storage

— Dilute and administer slowly; minimally over 6 hours using a smart infusion device with DERS

Shackney S and Hasson J. Ann Intern Med.1967;66:906-916. Stoff JS. Am J Med 1982;72:489-95


Michelle Mandrack, MSN, RNDirector of Consulting ServicesInstitute for Safe Medication [email protected]

High-Alert Medications: Magnesium Sulfate Injection

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Magnesium Sulfate Injection

— Important co-factor of many enzyme systems

— Indications:

• Hypomagnesemia

• Prevention of seizures in pre-eclampsia

• Control of seizures in eclampsia

• Fetal neuroprotection for preterm births

— Multiple risk factors in its safe use



High-Alert Medications: Magnesium

— Twenty-two (22) self-assessment items• 8 General items

• 3 items for treatment for hypomagnesemia

• 11 items for pre-eclampsia and eclampsia, and fetal neuroprotection

— 507 facilities submitted the magnesium section

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Low Scoring ItemsItem # Self-Assessment Item None

(A+B)Partial(C+D)

Full E

Mean(%)

8 To respond to emergencies caused by magnesium sulfate overdoses, a standard protocol has beenestablished that guides the administration of a rescue agent (i.e., calcium gluconate) after prescriber notification; and the rescue agent is easily accessible, along with directions for use, in all clinical areas where high-dose magnesium sulfate is administered.

43% 29% 27% 45%

11 During administration of intermittent doses of IV magnesium sulfate, the patient is assessed forsigns of toxicity (e.g., hypotension; respiratory depression; signs of pulmonary edema; bradycardia; cardiac arrhythmia; loss of deep tendon reflexes; progressive muscle weakness; decreased urine output; headache; clonus) at defined intervals (e.g., every 15 minutes for the first hour, every 30 minutes for the second hour, then hourly).

35% 38% 28% 51%



(A+B)Partial(C+D)

Full E

Mean(%)

9 Magnesium sulfate electrolyte replacement protocols have been established and are used to prevent and treat hypomagnesemia.

27% 34% 40% 62%

10 Standard order sets have been established and are used to prescribe magnesium sulfate to treat hypomagnesemia.

26% 32% 42% 64%

2 Parenteral magnesium sulfate protocols and order sets require periodic monitoring of magnesium blood levels, serum creatinine, and clinical patient assessments at defined intervals to determine the effectiveness of treatment and detect signs of toxicity.

19% 45% 36% 65%

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(A+B)Partial(C+D)

Full E

Mean(%)

22 Upon temporary stoppage of magnesium sulfate infusions, the solution is immediately disconnected from the patient. Exception: Short stoppages caused by conditions such as changing a gown.

20% 26% 54% 78%

16 Only 20 g/500 mL bags (not 40 g/1,000 mL bags) of magnesium sulfate are used for maintenance solutions to limit the amount of drug the patient could receive if an error occurs and to differentiate magnesium sulfate from other infusions in 1,000 mL bags (e.g., oxytocin, Lactated Ringer's).

29% 4% 68% 79%


Case Example— Order for a liter of 0.45% sodium chloride

injection with 20 mEq potassium chloride

— Nurse obtained the bag from the ADC and administered the infusion

— Patient had seizures and went into cardiac arrest

— Discovered incorrect bag of magnesium sulfate 40 g in water had been hung

— 40 g magnesium sulfate bags recently added to the ADC per ED staff request

— Using 20 g/500 mL magnesium bags can limit magnesium infused if errors occur

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— Consistent use of smart pump technology

— Loading doses of magnesium sulfate are administered by trained staff from a maintenance infusion bag, using only a smart infusion pump with dose error reduction software and a “loading dose” (sometimes called a “bolus dose”) feature that automatically starts/resumes the maintenance infusion at the prescribed rate of infusion once the loading dose has infused. • Loading doses are never administered via a basic infusion mode

• Mean 85%

Magnesium Infusion Opportunities


— A 24-week pregnant patient presented in the early stages of labor

— 6 grams of magnesium to be given as an IV bolus dose then continuous infusion of 2 g/hour

— Bolus dose programmed to run as a continuous rate of 12 g/hour outside drug library

• Nurse intended to reset the pump to run at 2 g/hour (the continuous rate) but forgot to return to the room

— Patient experienced difficulty in breathing, a significant drop in BP, and became unresponsive

— IV calcium gluconate given for magnesium toxicity • Magnesium level of 12.8 (therapeutic level is 6-8)

— Baby delivered via C-section and admitted to the Special Care Nursery for respiratory issues

Case Example

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Case Example— Magnesium bolus infusing as a piggyback

on smart pump, set to call back at end of bolus (30 minutes)

— Bag labeled with magnesium concentration• Tubing and pump were also labeled

— RN who took over patient’s care repeated the bolus dose of 4 grams in 30 minutes several times until the bag was almost empty

— Magnesium level was 8


— Most errors have been due to:• Unfamiliarity with safe dosage ranges and signs of toxicity • Inadequate patient monitoring

• Pump programming errors

• Line or bag mix-ups between:◦ Magnesium sulfate and oxytocin ◦ Magnesium sulfate and IV fluids

Magnesium Toxicity in Perinatal Care

http://www.ismp.org/Newsletters/acutecare/articles/20051020.asp

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Line or Bag Mix-ups

— Post precipitous delivery oxytocin bolus and infusion ordered

— Patient experienced hypotension, weakness and vomiting 1 hour later

— When replacing the oxytocin bag, nurse recognizes that magnesium had been infused

— Magnesium toxicity treated with calcium gluconate


— Order to run the lactated Ringer’s wide open

— Nurse mistakenly chose the magnesium sulfate infusion and ran it wide open instead

— Patient complained of feeling flushed

— Error discovered and the infusion was discontinued

Line or Bag Mix-ups

Medication Errors in Labor and Delivery: Reducing Maternal and Fetal Harm. Pa Patient Saf Advis. 2009 Dec 16;6 [Suppl 1]:1-6

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High Scoring Items: Dose Standardization

— Use a standard dosing unit of measure (mg or mg/kg; mEq or mEq/kg) for magnesium sulfate for neonates/pediatrics below a specific weight (Mean 92%)

— Use a standard dosing unit of measure (g or mEq) for magnesium sulfate for adult patients above a specific weight (Mean 93%)


High Scoring Items: Ready-to-Use Products

— Commercially available premixed bags of magnesium sulfate are used for:• All loading doses (Mean 98%)

• All maintenance infusions (Mean 94%)

www.ismp.org

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Magnesium Sulfate Safety

Establish and implement separate protocols and order sets per indication

Use standard dosing units (e.g., g vs. mEq; mg or mg/kg vs. mEq or mEq/kg)Protocols and

Order Sets

Establish a standard protocol for administration of the rescue agent calcium gluconate

Ensure calcium gluconate is readily available with directions for useEmergency

Preparedness

Use commercially available premixed bags or pharmacy-prepared infusions

Standardize to the use of 20 g/500 mL bags (not 40 g/1,000 mL bags) for pre-eclampsiaProducts



Always require administration via a smart infusion pump with DERSSmart Pump Technology

Administer loading doses via smart pump with bolus dose feature

Automatically starts/resumes the maintenance infusion at the

prescribed rate once the loading dose completeLoading Dose

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Utilize continuous cardiac monitoring and assess the patient for signs of toxicity (e.g., hypotension; respiratory depression; signs of pulmonary edema; bradycardia; cardiac arrhythmia; loss of deep tendon reflexes; progressive muscle weakness; decreased urine output; headache; clonus) at defined intervals during administration

Monitoring

Disconnect the magnesium sulfate immediately upon discontinuation or temporary stoppage of the infusion

Additionally, remove the container from the IV pole and discard when infusion is discontinued

Discontinuation or Temporary

Stoppage


Online Evaluation and Statement of CompletionPharmacy CE

— www.ProCE.com

— Login with username and password

— Deadline: February 25, 2022

Attendance Code = 9RPW4CAttendance Code = 9RPW4C

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baxter high alert webinar part 2 proce suggested revisions

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